The active substance is: tretinoin. 100g of cream contains 0.0500 g.
Excipients/Inactive Ingredients: The other ingredients are: isopropyl myristate, carbomer (CARBOPOL 1382), polysorbate 80, medium chain triglycerides (Miglyol 812), glycerol, light liquid paraffin, butylated hydroxytoluene, butylated hydroxyanisole, methyl parahydroxybenzoates, propyl parahydroxybenzoates, sodium hydroxide, purified water.
Pharmacotherapeutic group: This medicine is a topical anti-acne preparation (it acts directly on the area where it has been applied).
It is indicated to treat acne of moderate severity.
Dosage, administration method and frequency: Usually apply the cream once daily in the evening after washing (apply on the skin). After having washed and dried the skin, lightly massage a thin layer of the cream on the lesions, avoiding the eyes, eyelids, lips and nostrils. Wash hands after using the product.
Advise patient to seek advice from the doctor if the skin reacts too much, so the number and frequency of applications can be adjusted.
Treatment duration: The first signs of improvement generally appear after 4 to 8 weeks of treatment. The treatment must be continued for at least 3 months.
This initial treatment may be followed by a maintenance regimen.
Advise patient to always use this medicine exactly as prescribed.
Patient must not use this medicine if he/she is allergic (hypersensitive) to tretinoin (the active substance) or any of the other ingredients of this medicine (listed in Description).
Advise patient to ask a doctor or pharmacist for advice before using this medicine if in doubt.
Be careful with this medicine: Increasing the amount used will not improve the effectiveness or speed of action of the product and could cause redness, flaking (peeling skin) and discomfort.
Because of its activity, this cream is normally irritant to the skin. A certain number of precautions should be taken to reduce this effect: Ensure that the cream does not come into contact with the eyes, eyelids, nostrils or mouth. If contact accidentally occurs, carefully wash off with water.
If, before using this cream, the patient has already been treated with other topical exfoliating products (to smooth the skin), wait until the skin irritation disappears before beginning treatment.
Exposure to the sun and UV lamps will cause additional irritation. This being so, avoid exposure as much as possible during treatment. Treatment can nevertheless continue if exposure is reduced to a minimum (ensure protection by wearing a hat and using sunblock) and the number of applications is adjusted.
If exposed to the sun for longer than usual (e.g. spending a day at the beach), do not apply the cream the day before, on the day itself or the next day. If prior exposure has caused burning ("sunburn"), wait until it has fully settled before using the cream again.
When using this treatment, avoid using astringent (which dry the skin), drying or irritant cosmetic cleansers, perfumed products or products containing alcohol which could cause further irritation.
Patient can use her choice of makeup products for the lips and eyes, however, they should have an aqueous base only (contain water). Makeup such as powders and blushers may be used.
Regarding moisturising products, only those that do not contain oily components should be used to soothe facial dryness.
Advise patient to ask a doctor or pharmacist for advice before using this medicine, if in doubt.
Important information about some of the ingredients of this medicine: This medicine contains butylated hydroxyanisole (E320) and butylated hydroxytoluene (E321) which can cause local skin reactions (e.g. eczema) or irritate the skin, eyes and mucous membranes.
Because of the presence of methyl and propyl parahydroxybenzoates, there is a risk of eczema and, in exceptional cases, allergic reactions including urticaria (red, itchy plaques on the skin) and respiratory difficulties.
The effect of using this medicine during pregnancy is unclear.
For safety's sake, it is not recommended to use this medicine during pregnancy.
Patient should cease using the cream and seek advice from the doctor if she becomes pregnant during the course of treatment.
Before taking any medicines, patient should seek advice from the doctor or pharmacist.
Like all medicines, Ketrel 0.05% cream can cause side effects, although not everybody gets them.
In the first weeks of treatment, there may be worsening of the acne, in particular the appearance of small white-headed pustules.
This is normal. It is caused by the quicker elimination of the microcysts ("white heads") that were forming in the deeper layers of the skin.
Local side effects may occasionally appear in the form of irritations: diffuse redness, tingling, dryness of the skin, mild flaking (peeling skin).
These reactions are directly linked to the product's activity and disappear if a longer period is left between applications (e.g. 1 application every 2 days).
Some ingredients in this medicine, other than the active ingredient, can cause reactions (see Important information about some of the ingredients of this medicine under Precautions).
Patient should talk to the doctor or pharmacist if he/she gets any side effects. This includes any possible side effects not listed in this monograph.
Be advised if patient is taking or has recently taken any other medicines, including medicines obtained without a prescription.
Store below 25°C.
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer in use. These measures will help protect the environment.
D10AD01 - tretinoin ; Belongs to the class of topical retinoid preparations used in the treatment of acne.
Ketrel cream 0.05%
30 g x 1's
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